In 2005, a couple of guys in Waterford, Ireland, got together and said: “There’s not enough high-potency, high-containment facilities in the world. Why not build one?” While they were at it, they also decided to focus a new facility on developing and producing innovative generics. What could be so easy?
In order to effectively extend the capacity of its organization using external partners, Merck & Co., Inc. decided to shift from limited, tactical, piecemeal outsourcing to a strategic outsourcing model. This article summarizes the first five of 10 key elements — or best practices — that were critical for the successful implementation of its strategic partnerships.
The first two articles in this series discussed the physical elements of facility design that sponsors look for in their contract development and manufacturing organizations (CDMOs) and sponsor requirements for dedicating equipment to GMP operations, equipment redundancy, and immediate disclosure of equipment and facility issues. This article presents solutions to improve transparency during sponsor audits of CDMOs.
The FDA recently issued a draft guidance entitled “Quality Considerations for Continuous Manufacturing” in an effort to advance greater predictability for companies adopting CM technology. Specifically, the FDA hopes this draft guidance will support the development and adoption of CM for brand, generic, and over-the-counter drugs.
This paper examines the opportunities and challenges of conducting clinical trials in China, and offers proven strategies for overcoming hurdles.
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
In the bioprocessing industry, in order to make full use of upstream advances in an efficient manner, it is essential that downstream processes are intensified.
When developing a parenteral product, pharmaceutical scientists are faced with a variety of choices — choices that can be conflicting or present differing advantages.
Sterile suspensions are particularly difficult to manufacture. This technical article covers factors for success, including particle size, vehicle formulation, and considerations for high-shear mixing.
Supply chain management has advanced rapidly over the past decade, evolving from what was once dubbed “materials management” into the essential glue that binds all aspects of a business’ internal and external collaborations.
Opioids are used to treat both acute and chronic pain; however, traditional μ-opioids are often associated with opioid-induced side effects that can limit treatment effectiveness. Issues with tolerability have led to the development of novel opioids that may have a more favorable adverse event profile.
Outsourced Pharma provides comprehensive analysis and exclusive content from thought leaders for the advancement of global outsourcing of drug development and manufacturing. We offer readers of our website and participants of our conferences – our Outsourced Pharma community – a deeper exploration and understanding of the relationships between pharmaceutical and biotechnology organizations with their service providers, and an open channel of communication.
About Outsourced Pharma Conferences
Outsourced Pharma Conference & Exhibition is a vibrant forum for thought-leadership and the application of best practices for professionals engaged in outsourcing drug development and manufacturing. These conferences and exhibitions form a community for networking and discussing topics most relevant to sponsor-provider partnerships and supply-chain management, within an open format that promotes panel and attendee interaction.
OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
Technology transfer involves manufacturing drug product with increasing batch sizes on larger equipment or using continuous processing on pilot scale equipment.
It is critical drug that manufacturers understand the differences between the formulation development approaches OVAT and QbD to mitigate risk and preserve product performance.
Drug substance characterization is critical to drug product formulation but characterization and formulation are often not integrated during drug development.
A company has to be able to withstand the highs and lows of biologics development. To avoid costly mistakes and wasted efforts, a company must prepare for surprises along the drug development pathway.
What strategies should your company consider for recruiting, training, and retaining qualified candidates in order to remain competitive in a burgeoning biopharma market?